AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

Sponsor
Harbin Medical University
Study ID
NCT06196697
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cadonilimab — BIOLOGICAL
    Subjects will receive AK104 by intravenous administration
  • Ivonescimab — BIOLOGICAL
    Subjects will receive AK112 by intravenous administration
  • XELOX — DRUG
    Subjects will receive AK104 and AK112 in combination with XELOX(oxaliplatin and capecitabine)
  • SOX — DRUG
    Subjects will receive AK104 and AK112 in combination withSOX(oxaliplatin and Tegafur)

Study Details

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

Key Dates

Start date
Apr 10, 2024
Status verified
Jun 2024
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AK104+AK112+SOX/XELOX
    Biological: Cadonilimab (AK104) 10mg/kg or 15mg/kg or 6mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) Biological: Ivonescimab (AK112): 20mg/kg Q3W iv D1 Drug:SOX or XELOX SOX: Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Tegafur (40 mg/m2, p.o., Bid, Q3W, for day 1 to day 14 per cycle) XELOX: Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+Capecitabine(1000 mg/m2, p.o., Bid, Q3W, for day 1 to day 14 per cycle)

Primary Outcome Measure

Objective Response Rate,ORR [ Time Frame: 6 months ]

Central Contacts

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